New Law on Clinical Trials on the Anvil

by Rajshri on  February 9, 2010 at 7:25 PM Medico Legal News   - G J E 4
 New Law on Clinical Trials on the Anvil
In a bid to regulate the booming clinical trial market, the Union Health Ministry of India has revealed that it will be reviewing the Bill for Research on Human Subjects with a new draft expected to be readied by the end of next month.

According to consultancy firm Ernst and Young, the clinical trial market in India has an annual growth rate of 30 percent and is currently valued at Rs1,400 crore. While the country is fast becoming the preferred destination to conduct clinical trials, a strong law to regularize such trials is absent.

However V.M. Katoch, who is the head of department of health research with the health ministry, revealed that the revised law will be drafted within two months and said that any violations will be dealt with strong punishment.

"If any violations occur in trials here, the punishment should be as stringent as it is in other countries where these (multinational drug) companies do research. Human dignity in research is something we will tackle in this Bill", Katoch added.

Source: Medindia

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